ICH Q7 Compliance Week

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At the end of 2020, the ICH Q7 Training Week was held as a live online event for the first time. The ICH Q7 Training Week from June 21-25, 2021 was now also successfully held as a digital event. In addition to new speakers and tried-and-tested, constantly updated sessions, this year's training week was distinguished by a new, online lecture concept (see Figure 1). The event was once again supported by the representative of the APIC Task Force "Third Party Manufacturing" Dr Jens Brillault.

Participants of the Compliance Courses selected one of two key topics in advance: "ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis" or "ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation". In accordance with the new lecture concept, on Day 1 and Day 2 of the training week, both groups of participants were introduced to compliance topics from the areas of chemical and biotechnological manufacturing of active pharmaceutical ingredients (APIs) together. Lectures were held on the topics GMP and legal requirements of active pharmaceutical ingredients.

On the morning of the third day, the groups of participants were split into so-called Parallel Sessions in order to further deepen their knowledge in their chosen key area.

Following this was the auditor course of the APIC Audit Program of the ICH Q7 Training Week. This year, the course was characterized by the great participation and interactivity of the participants and speakers. During the two days of the auditor course, not only surveys, presentations and Q&A sessions, but also the execution, presentation and subsequent analysis of role plays took a central position and shed light on the new daily audit routine created by the corona pandemic - remotely and onsite.

Fig 1: Overview of the ICH Q7 Training Week

Monday, Joint Programme, Part 1

Dr Jens Brillault, as a representative of APIC, a sector group of the European Chemical Industry Council (CEFIC), opened the first day of the course and presented the activities of APIC and its publications, such as the new edition of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs. Subsequently, the compliance course day was characterized by the presentation and explanation of ICH and its Quality (Q) guidelines by Francois Vandeweyer and the responsibilities and tasks of the Q units of the manufacturing pharmaceutical companies by Dr Paul Stockbridge. As a further focus of the first day of the course, the topic of GMP inspections was examined from a wide variety of viewpoints by the speakers Dr Frank Sielaff , Francois Vandeweyer and Dr Paul Stockbridge. In addition to presenting the most common deficiencies that can occur during GMP inspections at API manufacturing sites and the most important points regarding inspection preparation, Dr Frank Sielaff presented the view of the regulatory authority with regard to API inspections and their requirements for the first time, and will from now on be a member of the speaker team at the ICH Q7 Training Week.

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Tuesday, Joint Programme, Part 2

The second day of the Compliance Courses was dedicated to "Life cycle management and continuous improvement" in the area of active pharmaceutical ingredients.

Dr Markus Dathe opened the course day with his presentation on "API in IMP" and introduced the risk-based approach in detail.

Dr Paul Stockbridge and Francois Vandeweyer took over at that point on the second day of the course and outlined the steps required by the ICH Q7 guideline for supplier qualification as well as making suggestions for strategies to reduce the volume of tests. Furthermore, the topics of change control management and the implementations of the ICH Q3D requirements were dealt with in depth and the topic of stability studies and their testing was highlighted. Francois Vandeweyer gave detailed advice and suggestions for actions in this regard and dealt in detail with the questions and comments of the participants. Another main topic was the presentation of the "Questions and Answers" document of the ICH Q7 Guideline, which is intended to be a further aid to understanding the ICH Q7 requirements and which Francois Vandeweyer skillfully placed in the context of the APIC publication "How to do" - Document - Interpretation of ICH Q7 Guide and "Review form" for active substances.

Wednesday, Parallel Sessions, Part 3

For the third Compliance Course day, the audience split into two groups - one part listened to presentations around chemically manufactured APIs, while the second part gained insights into biotechnological API manufacturing.

The four presentations given in the chemically manufactured API block included the topics of purification validation, equipment qualification and calibration, their design and process validation, and were presented by Peter Mungenast, Ralf Gengenbach and Dr Paul Stockbridge.

Walter Tabotta, Stephan Löw, Paul Lopolito and Dr Paul Stockbridge were the speakers of the biotech course and explained in their lectures the way of GMP inspections for biotech manufacturing companies and procedures for cleaning the used equipment as well as its cleaning validation. They also highlighted the risks of viral contamination and, in the last presentation of the day, provided insights into the topic of cell banks and their testing and qualification.

Wednesday, ICH Q7 Auditor Training Course

As usual, the Auditor Training Course of the ICH Q7 Training Week followed the Compliance Courses.

Dr Jens Brillault opened the course as APIC representative and gave a detailed overview of the APIC Audit Program and the activities of the APIC working groups. The requirements and prerequisites that APIC places on auditors were clearly listed and explained. Francois Vandeweyer then presented specific audit situations and showed how to prepare for them. Using surveys, he guided participants through each scenario and helped them develop solutions to specific issues, concluding the first day of the auditor training.

Thursday, ICH Q7 Auditor Training Course

From now on, both speakers together demonstrated how to write audit reports in general and in particular according to APIC requirements and according to which criteria audit deficiencies can be classified.

In addition, Francois Vandeweyer gave the participants the riskbased approach as a way to prepare and conduct an audit.

Peter C. Zimmermann added to the course day with a presentation of communication types and styles and highlighted cultural differences in this regard. In addition to individual presentations, role plays were completed by the participants and speakers in order to recognize and internalize important communication characteristics. Again, surveys and Q&A sessions were important components in explaining the topics and were backed up by constant feedback from the speaker. The fourth day of the course concluded with the preparation and execution of the first audit execution role play.

Friday, ICH Q7 Auditor Training Course

The last day of the ICH Q7 training week started with the highlighting of the possibilities and innovations through remote audits. Due to the special situation created by the corona pandemic in 2020 and the resulting changes in the pharmaceutical industry, the topic of remote audits was of great importance throughout the entire auditor training course and was examined again in detail in the presentation by Francois Vandeweyer and Peter C. Zimmermann. This was followed by two further role plays and their analyses, both of which were intended to reproduce a classic audit situation, and were always supported by the speakers' tips and comments, giving the participants the opportunity to test their skills as both auditors and auditees. How to end an audit and present the deficiencies in a factual way was shown in the last presentation of the ICH Q7 Training Week and explained with examples. The final Q&A session was followed by the final written exam for some of the participants seeking APIC Audit Program certification, which traditionally marks the end of the ICH Q7 Training Week.

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This year, the ICH Q7 Training Week was yet again characterized by the questions and comments of the participants, to which the speakers were always happy to respond and suggest solutions. After the course week, all participants also received the new edition of the "ICH Q7 Side-by-Side Comparison" ring binder by mail in addition to the participant certificates. Even though the ICH Q7 Training Week 2021 could not be conducted as an on-site event, this long-held tradition will remain.

Note: The ICH Q7 Training Week will again take place online from 20-24 June 2022. Among many other topics, this will include an overview of APIs in IMPs and the respective regulations. This year's ICH Q7 Week auditor course will again feature new aspects of remote auditing - on the one hand through the speakers' presentations and case studies, and on the other hand through the audit situations presented online by the participants. Further information can be found on the "ICH Q7 Week" website!

 

About the Author
Anne Theresa Günster joined CONCEPT HEIDELBERG in 2019 and organises and conducts courses and conferences on behalf of the ECA Academy in the areas API Manufacturing, Regulatory Affairs, Documentation and Laboratory Data Integrity.

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